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Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740440
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : March 24, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Bio-Medical Research, Ltd.

Tracking Information
First Submitted Date  ICMJE November 21, 2012
First Posted Date  ICMJE December 4, 2012
Results First Submitted Date  ICMJE July 17, 2014
Results First Posted Date  ICMJE March 24, 2016
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline. [ Time Frame: 12 weeks ]
Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4).
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Evaluate the Efficacy of the BMR Face Device in Relation to Facial Appearance at 12 Weeks Compared to Baseline. [ Time Frame: 12 weeks ]
Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2016)
  • To Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Including the Global Aesthetic Improvement Scale (GAIS) at 6 Weeks Compared to Baseline [ Time Frame: 6 weeks ]
    Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4).
  • To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). [ Time Frame: 6 weeks, 12 weeks ]
    The Subject Satisfaction Assessment Scale is a 5 point scale where a subject rates their satisfaction level as Very Satisfied, Satisfied, No Opinion, Unsatisfied or Very Unsatisfied.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Secondary objectives are to evaluate safety and further evaluate the subject's and investigator's satisfaction (both a live and blinded assessor) with the BMR Face treatment. [ Time Frame: 6 weeks and 12 weeks ]
    Adverse events will be monitored to assess safety.
  • Subject satisfaction with the BMR Face Treatment [ Time Frame: 6 and 12 weeks ]
    Subject satisfaction will be measured using subject-completed questionnaire
  • Subject Photographs Taken to Assess Outcome of Using BMR Face [ Time Frame: Baseline, 6 and 12 weeks ]
    Subject photographs will be used to assess the overall facial appearance including Subject photographs will be used to assess overall facial appearance using the Global Aesthetic Improvement Scale
  • Investigator Satisfaction of BMR Face Treatment [ Time Frame: 6 weeks and 12 weeks ]
    Investigator's satisfaction with the BMR Face treatment using questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance
Official Title  ICMJE Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance
Brief Summary Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)
Detailed Description

Evaluate the efficacy of the BMR Face device in relation to facial appearance at 12 weeks compared to baseline. Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).

The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement

Secondary objectives are to evaluate safety and further evaluate the subject's and investigator's satisfaction (both a live and blinded assessor) with the BMR Face treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Ageing
Intervention  ICMJE Device: BMR Face
BMR Face used in accordance with manufacturer IFU
Study Arms  ICMJE BMR Face treatment
BMR Face treatment used once a day for 12 weeks
Intervention: Device: BMR Face
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization
  • Subjects who are healthy females between 35 and 55 years of age
  • Subjects with a Body Mass Index (BMI) between 15-35 kg/m2 (light underweighted to light obese)
  • Subjects may have all skin types
  • Subjects with age related skin laxity in the treatment area
  • Subjects who agree not to have any procedures affecting facial volume (any fillers or fat transfer) for the duration of the study
  • Subjects who agree not to have any other procedures affecting skin quality (microdermabrasion, resurfacing, peels, lasers, acne treatments, etc.) for the duration of the study
  • Subjects who agree to make no changes in their existing skincare regime during the study period
  • Subjects who agree to avoid excessive sun radiation or use appropriate sun protection with SPF 30 or higher
  • Subjects who agree not to alter their diet for the duration of the study
  • Subjects who understand this study and are able to follow study instructions and are willing to attend the required study visits
  • Subjects who agree to be photographed for the purposes of the study and give consent for these photographs to be used in marketing advertisements where their identity will not be concealed in these photographs

Exclusion Criteria:

  • Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
  • Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence)
  • Subjects who cannot understand or are not willing to comply with the requirements of the study
  • Subjects who have any dermatologic conditions including acne, rosacea, eczema, psoriasis, severe sun damage or scars within the treatment area
  • Subjects who have any known cancer including skin cancers (Basal Cell Carcinoma, Squamous Cell Carcinoma and Melanoma)
  • Subjects with a history of heart disease or stroke
  • Subjects who have any active implanted medical devices (pacemaker, pump etc)
  • Subjects having any metal implants. Dental implants and fillings are allowed as well as piercings as long as they are not in the treatment area.
  • Subjects who have used a tanning bed in the past four weeks or plan to use a tanning bed for the duration of the study
  • Subjects who are HIV positive
  • Subjects who have had systemic corticosteroid therapy in the past 6 months
  • Subjects who have had a facial dermabrasion, chemical peel, laser, or IPL treatment in the past 6 months
  • Subjects who have used botulinum toxin, hyaluronic acid, collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in the past 6 months
  • Subjects who have had ablative resurfacing procedure, brow lift, blepharoplasty or face lift in treated area in the past 12 months
  • Subjects who have had any other surgery in treated area in the past 12 months
  • Subjects who have an existing medical condition that the Investigator considers may put the subject at risk or compromise their participation in the study
  • Subjects who have participated in another research study in the past 30 days
  • Subjects who are currently involved in any injury litigation claims
  • Subjects who have used the BMR Face device previously
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740440
Other Study ID Numbers  ICMJE SRG-BMR Face01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bio-Medical Research, Ltd.
Study Sponsor  ICMJE Bio-Medical Research, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neil Sadick, Dr Sadick Research Group
PRS Account Bio-Medical Research, Ltd.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP